FDA.reportPublic FDA data

fungoid tincture

Product NDC
0884-0293
11-digit product format
008840293
Labeler code
0884
Product ID
0884-0293_24ae5b13-853c-1311-e063-6394a90aa6ac
Type
HUMAN OTC DRUG
Nonproprietary name
miconazole nitrate
Dosage form
TINCTURE
Route
TOPICAL
Labeler
Pedinol Pharmacal, Inc.
Application
M014
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-04-11
Substance
MICONAZOLE NITRATE
Active strength
20 mg/mL
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
fungoid tincture
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVW4H1CYW1K
Rxcui998525, 998526

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0884-0293-01fungoid tincture29.57 mL in 1 BOTTLE, WITH APPLICATORTINCTURE29.578
0884-0293-01fungoid tincture1 in 1 CARTONTINCTURE18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0884-0293-01ML - Milliliter0884-0293c8854e7a-8786-48ac-91e1-b9ab9ded773112014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Miconazole NitrateACTIVE INGREDIENTVW4H1CYW1KFUNGOID TINCTURE (MICONAZOLE NITRATE) TINCTURE [PEDINOL PHARMACAL, INC.]1
MiconazoleACTIVE MOIETY7NNO0D7S5MFUNGOID TINCTURE (MICONAZOLE NITRATE) TINCTURE [PEDINOL PHARMACAL, INC.]1
Acetic AcidINACTIVE INGREDIENTQ40Q9N063PFUNGOID TINCTURE (MICONAZOLE NITRATE) TINCTURE [PEDINOL PHARMACAL, INC.]1
Benzyl AlcoholINACTIVE INGREDIENTLKG8494WBHFUNGOID TINCTURE (MICONAZOLE NITRATE) TINCTURE [PEDINOL PHARMACAL, INC.]1
Isopropyl AlcoholINACTIVE INGREDIENTND2M416302FUNGOID TINCTURE (MICONAZOLE NITRATE) TINCTURE [PEDINOL PHARMACAL, INC.]1
Laureth-4INACTIVE INGREDIENT6HQ855798JFUNGOID TINCTURE (MICONAZOLE NITRATE) TINCTURE [PEDINOL PHARMACAL, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RFUNGOID TINCTURE (MICONAZOLE NITRATE) TINCTURE [PEDINOL PHARMACAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0884-0293FUNGOID TINCTURE (MICONAZOLE NITRATE) TINCTURE [PEDINOL PHARMACAL, INC.]8Current NDC, Legacy NDC, 2 package rows20241019_250d0a66-01d1-4aba-8f24-4cb4ca529fda.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998526Fungoid 2 % tincture treatment kitPSN250d0a66-01d1-4aba-8f24-4cb4ca529fda8
998525miconazole nitrate 2 % Topical SolutionPSN250d0a66-01d1-4aba-8f24-4cb4ca529fda8
998526miconazole nitrate 20 MG/ML Topical Solution [Fungoid]SBD250d0a66-01d1-4aba-8f24-4cb4ca529fda8
998525miconazole nitrate 20 MG/ML Topical SolutionSCD250d0a66-01d1-4aba-8f24-4cb4ca529fda8
998526Fungoid 2 % Topical TinctureSY250d0a66-01d1-4aba-8f24-4cb4ca529fda8
998526Fungoid 20 MG/ML Topical SolutionSY250d0a66-01d1-4aba-8f24-4cb4ca529fda8
998525miconazole nitrate 2 % Topical SolutionSY250d0a66-01d1-4aba-8f24-4cb4ca529fda8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0884-0293-01008840293011 BOTTLE, WITH APPLICATOR in 1 CARTON (0884-0293-01) / 29.57 mL in 1 BOTTLE, WITH APPLICATOR2012-04-110000-00-00NoNoCurrent